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Zantac Contaminated with NDMA New York Class Action

If too many samples of a certain drug are found to be contaminated, shouldn’t sales of the drug be suspended until the contamination problem has been resolved? The complaint for this class action alleges that Sanofi-Aventis US, LLC, Sanofi US Services, Inc. and Chattem, Inc. have failed to pull their drug Zantac off the market, even though it is a brand-name version of the contaminated drug.

The class for this action is all persons in New York who bought Zantac over-the-counter, between January 1, 2017 and the present.

The drug at issue here is ranitidine, a popular drug for treating heartburn, ulcers, and gastroesophageal reflux. It is available both over-the-counter and by prescription. It is generally considered safe and inexpensive. Zantac is a brand name for ranitidine from Sanofi.

On September 9, 2019, the pharmacy Valisure sent the Food and Drug Administration (FDA) a petition asking that the FDA suspend sales of ranitidine. This was because it had tested samples of ranitidine and “detected extremely high levels of N-Nitrososdimethylamine (“NDMA”), a probable human carcinogen according to the WHO, in every lot tested, across multiple manufacturers and dosage forms.”

The World Health Organization (WHO) classifies NDMA as a probably carcinogen.

How did the NDMA get into the drug? The complaint says, “According to Valisure, ranitidine reacts with itself due to a molecular instability, and produces NDMA levels in excess of 3,000,000 ng per 150mg tablet, which is more than 31,000 times the FDA’s maximum daily intake amount of 96 ng/day. Valisure tested several brands of ranitidine including Zantac and drugstore brands, and each sample had levels of NDMA in excess of 2.4 million ng per 150mg tablet.”

Even worse, the complaint says, “testing designed to simulate what happens to ranitidine in the human body shows that ingestion of ranitidine results in exposure to unacceptably high levels of NDMA.”

The FDA issued a MedWatch Alert on September 13; on September 24, it issued an alert for a voluntary recall of fourteen lots of ranitidine distributed by Sandoz. It also asked drug makers to begin testing their own ranitidine drugs. Three days later it announced another voluntary recall of ranitidine under the labels of Walmart, Walgreens and Rite-Aid. On October 2, it announced it had found “unacceptable levels of NDMA” in samples.

Since then, other countries, including Austria, Canada, Finland, Germany, Pakistan, Singapore, Switzerland, and the UAE have all suspended ranitidine sales. 

At long last, on October 18, 2019, Sanofi recalled over-the-counter Zantac. The complaint claims, “Sanofi either knew or had reason to know that ranitidine drugs, including Zantac, exposure users to unsafe levels of NDMA when used as directed.” However, it says, Sanofi continued to sell the drug and did not disclose this to consumers, which was “deceptive and misleading.”

Article Type: Lawsuit
Topic: Consumer

Most Recent Case Event

Zantac Contaminated with NDMA New York Complaint

November 12, 2019

If too many samples of a certain drug are found to be contaminated, shouldn’t sales of the drug be suspended until the contamination problem has been resolved? The complaint for this class action alleges that Sanofi-Aventis US, LLC, Sanofi US Services, Inc. and Chattem, Inc. have faield to pull their drug Zantac off the market, even though it is a brand-name version of the contaminated drug.

sanofi_zantac_contamination_complaint.pdf

Case Event History

Zantac Contaminated with NDMA New York Complaint

November 12, 2019

If too many samples of a certain drug are found to be contaminated, shouldn’t sales of the drug be suspended until the contamination problem has been resolved? The complaint for this class action alleges that Sanofi-Aventis US, LLC, Sanofi US Services, Inc. and Chattem, Inc. have faield to pull their drug Zantac off the market, even though it is a brand-name version of the contaminated drug.

sanofi_zantac_contamination_complaint.pdf
Tags: Contaminated Drugs, Contaminated with Harmful Substances, Pharmaceuticals